A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
- Conditions
- Interventions
- Registration Number
- NCT05195528
- Lead Sponsor
- Phathom Pharmaceuticals, Inc.
- Brief Summary
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 776
- The participant is ≥18 years of age at the time of informed consent signing.
- In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements, including compliance with the electronic diary.
- The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
- The subject has a diagnosis of symptomatic gastroesophageal reflux disease (GERD) with heartburn as the subject's predominant symptom prior to the Screening Period, as documented in the subject's medical record.
- History of onset of heartburn at least 6 months prior to the Screening Period.
- Heartburn reported on 4 or more days during any consecutive 7-day period of the Screening Period as recorded in the electronic diary.
- A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.
-
The participant has endoscopically confirmed erosive esophagitis (EE) during the Screening Period. Endoscopy conducted during the Screening Period should be performed after participants meet Inclusion Criterion 6 (i.e., heartburn reported on 4 or more days during any consecutive 7-day period of the Screening Period as recorded in the electronic diary).
-
The participant has active irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.
-
The participant has a history of or is suspected of having functional upper gastrointestinal disorders, such as:
- Functional heartburn, as described in the Rome IV Criteria.
- Functional dyspepsia, as described in the Rome IV Criteria.
-
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
-
The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.
-
The participant has scleroderma (systemic sclerosis) or systemic lupus erythematosus.
-
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except dilation for a Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
-
The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
-
The participant requires or is expected to require use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
-
The participant has received any investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period or vonoprazan in a clinical trial at any time (including participation in Study NERD-201). A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
-
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
-
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to the Screening Period.
-
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
-
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, and titanium oxide, or red or yellow ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
-
The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen for cannabinoids/tetrahydrocannabinol (including prescription cannabinoids) and non-prescribed medications during the Screening Period.
-
The participant is taking any excluded medications or treatments listed in the protocol, including prescription cannabinoids/tetrahydrocannabinol.
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If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
-
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
-
The participant requires hospitalization or has surgery scheduled during the course of the study (from Visit 1 to end of Follow-up Period at Visit 10) or has undergone major surgical procedures within 30 days prior to the Screening Period.
-
The participant has a history of malignancy (including mucosa-associated lymphoid tissue lymphoma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
-
The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody, or HCV-ribonucleic acid (RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.
-
The participant has any of the following abnormal laboratory test values at the start of the Screening Period:
- Creatinine levels: >2 mg/dL (>177 μmol/L).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except for participants with a diagnosis of Gilbert's syndrome).
-
The subject tests positive for active H pylori infection during the Screening Period, after ≥4 weeks free from antibiotics and bismuth and ≥2 weeks free from PPIs and histamine-2 receptor antagonists (H2RAs).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will be administered the placebo QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to placebo in the Placebo-controlled Treatment Period will be re-randomized to receive either vonoprazan 10 mg QD or vonoprazan 20 mg QD in the 20 week Extension Period. Vonoprazan 10 mg Vonoprazan Participants will be administered vonoprazan at a dose of 10 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 10 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period. Vonoprazan 20 mg Vonoprazan Participants will be administered vonoprazan at a dose of 20 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 20 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period.
- Primary Outcome Measures
Name Time Method Percentage of Days Without Daytime or Nighttime Heartburn Day 1 to Day 28 Participants were assigned an electronic diary to complete twice daily, in the morning and evening. Diary day was considered heartburn-free if both morning and evening diary entries were heartburn-free and there was no reported use of rescue antacid, H2RAs, or PPIs.
- Secondary Outcome Measures
Name Time Method Percentage of Days Without Rescue Antacid Use Day 1 to Day 28 Participants were assigned an electronic diary to complete twice daily, in the morning and evening. Participants recorded use of rescue antacid.
Trial Locations
- Locations (106)
Paragon Rx Clinical
🇺🇸Garden Grove, California, United States
East View Medical Research, LLC
🇺🇸Mobile, Alabama, United States
Medical Affiliated Research Center Inc
🇺🇸Huntsville, Alabama, United States
Clinical Research Partners LLC
🇺🇸Richmond, Virginia, United States
Cullman Research Center
🇺🇸Cullman, Alabama, United States
Prospective Research Innovations
🇺🇸Rancho Cucamonga, California, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Del Sol Research Management - Clinedge
🇺🇸Tucson, Arizona, United States
GW Research, Inc
🇺🇸Chula Vista, California, United States
eStudy Site
🇺🇸Chula Vista, California, United States
BG Clinical Research
🇺🇸Encinitas, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
Torrance Clinical Research Institute
🇺🇸Lomita, California, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Northern California Research Corp
🇺🇸Sacramento, California, United States
Washington Gastroenterology
🇺🇸Bellevue, Washington, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
North Alabama Research Center LLC
🇺🇸Athens, Alabama, United States
OM Research LLC
🇺🇸Lancaster, California, United States
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Gastroenterology Associates of Central Georgia, LLC
🇺🇸Macon, Georgia, United States
East Carolina Gastroenterology
🇺🇸Jacksonville, North Carolina, United States
Texas Gastro Consultants
🇺🇸Tomball, Texas, United States
Primecare Medical Group
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Office of Site 2
🇺🇸Las Vegas, Nevada, United States
Gastro Health Research
🇺🇸Cincinnati, Ohio, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Office of Site 1
🇺🇸Las Vegas, Nevada, United States
MNGI Digestive Health
🇺🇸Minneapolis, Minnesota, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
Gastroenterology Research of San Antonio (GERSA)
🇺🇸San Antonio, Texas, United States
Southern Star Research Institute LLC
🇺🇸San Antonio, Texas, United States
QUALITY Medical Research
🇺🇸Nashville, Tennessee, United States
Vanderbilt Digestive Disease Center
🇺🇸Nashville, Tennessee, United States
Kalo Clinical Research
🇺🇸Salt Lake City, Utah, United States
Quality Clinical Research - HyperCore
🇺🇸Omaha, Nebraska, United States
Elite Clinical Studies - Phoenix - Clinedge
🇺🇸Phoenix, Arizona, United States
Preferred Research Partners - ClinEdge
🇺🇸Little Rock, Arkansas, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Clinical Applications Laboratories Inc
🇺🇸San Diego, California, United States
Paragon Rx Clinical, Inc.
🇺🇸Santa Ana, California, United States
Velocity Clinical Research - New Smyrna Beach
🇺🇸Edgewater, Florida, United States
Connecticut Clinical Research Institute
🇺🇸Bristol, Connecticut, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
ENCORE Borland-Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
ClinCloud
🇺🇸Maitland, Florida, United States
Digestive Disease Consultants, PA
🇺🇸Orange Park, Florida, United States
Medical Center
🇺🇸Orlando, Florida, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Guardian Angel Research
🇺🇸Tampa, Florida, United States
Southeast Clinical Research Center
🇺🇸Dalton, Georgia, United States
Atlanta Center For Gastroenterology PC
🇺🇸Decatur, Georgia, United States
Atlanta Center For Clinical Research
🇺🇸Roswell, Georgia, United States
In Quest Medical Research
🇺🇸Suwanee, Georgia, United States
Grand Teton Research Group, PLLC
🇺🇸Idaho Falls, Idaho, United States
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
Clinical Trials Management LLC
🇺🇸Covington, Louisiana, United States
Digestive Health Specialists
🇺🇸Chelmsford, Massachusetts, United States
Tandem Clinical Research, LLC
🇺🇸Marrero, Louisiana, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Clinical Trials of America, LLC
🇺🇸West Monroe, Louisiana, United States
Combined Gastro Research
🇺🇸Lafayette, Louisiana, United States
Gastroenterology Associates of Western Michigan, PLC
🇺🇸Wyoming, Michigan, United States
Minnesota Gastroenterology PA
🇺🇸Plymouth, Minnesota, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
The Gastroenterology Group of Northern NJ LLC
🇺🇸Englewood, New Jersey, United States
Advanced Research Institute
🇺🇸Sandy, Utah, United States
Allied Health Clinical Research Organization
🇺🇸Freehold, New Jersey, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Care Access Research
🇺🇸New York, New York, United States
NY Scientific
🇺🇸Brooklyn, New York, United States
UNC Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology PLLC
🇺🇸Charlotte, North Carolina, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
Clinical Trials of America-NC, LLC
🇺🇸Mount Airy, North Carolina, United States
Trial Management Associates LLC
🇺🇸Wilmington, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
Remington Davis Clinical Research
🇺🇸Columbus, Ohio, United States
Great Lakes Medical Research LLC
🇺🇸Mentor, Ohio, United States
North Shore Gastroenterology
🇺🇸Westlake, Ohio, United States
Frontier Clinical Research, LLC
🇺🇸Uniontown, Pennsylvania, United States
Susquehanna Research Group, LLC
🇺🇸Harrisburg, Pennsylvania, United States
Galen Medical Group
🇺🇸Hixson, Tennessee, United States
Gastro One
🇺🇸Cordova, Tennessee, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
Digestive Health Associates of Texas, PA
🇺🇸Carrollton, Texas, United States
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
🇺🇸Garland, Texas, United States
Texas Tech Physicians of El Paso
🇺🇸El Paso, Texas, United States
Family Medicine Associates of Texas
🇺🇸Carrollton, Texas, United States
Gastroenterology Consultants of South Texas, PLLC
🇺🇸Brownsville, Texas, United States
Rio Grande Gastroenterology
🇺🇸McAllen, Texas, United States
Sherman Clinical Research
🇺🇸Sherman, Texas, United States
GI Alliance
🇺🇸Southlake, Texas, United States
Texas Digestive Disease Consultants
🇺🇸Southlake, Texas, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
Legacy Clinical Solutions: Sensible HealthCare, LLC
🇺🇸Ocoee, Florida, United States
Gastroenterology Associates, PA of Greenville
🇺🇸Greenville, South Carolina, United States
Digestive Care Center
🇺🇸San Carlos, California, United States
Western States Clinical Research Inc
🇺🇸Wheat Ridge, Colorado, United States
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
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